Orserdu

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

elacestrant

Saadav alates:

Stemline Therapeutics B.V.

ATC kood:

L02BA

INN (Rahvusvaheline Nimetus):

elacestrant

Terapeutiline rühm:

Endocrine therapy

Terapeutiline ala:

Breast Neoplasms

Näidustused:

Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2023-09-15

Infovoldik

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORSERDU 86 MG FILM-COATED TABLETS
ORSERDU 345 MG FILM-COATED TABLETS
elacestrant
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ORSERDU is and what it is used for
2.
What you need to know before you take ORSERDU
3.
How to take ORSERDU
4.
Possible side effects
5.
How to store ORSERDU
6.
Contents of the pack and other information
1.
WHAT ORSERDU IS AND WHAT IT IS USED FOR
WHAT ORSERDU IS
ORSERDU contains the active substance elacestrant which belongs to a
group of medicines called
selective estrogen receptor degraders.
WHAT ORSERDU IS USED FOR
This medicine is used to treat postmenopausal women and adult men who
have a specific type of
breast cancer that is advanced or has spread to other parts of the
body (metastatic). It can be used to
treat breast cancer that is estrogen receptor (ER)-positive, meaning
that the cancer cells have receptors
for the hormone oestrogen on their surface, and that is human
epidermal growth factor receptor 2
(HER2)-negative, meaning that cancer cells have no or only a small
amount of this receptor on their
surface. ORSERDU is used as monotherapy (used on its own) in patients
whose cancer has not
responded to or progressed further following at least one line of
hormon

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
ORSERDU 86 mg film-coated tablets
ORSERDU 345 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ORSERDU 86 mg
film-coated tablets
Each film-coated tablet contains elacestrant dihydrochloride
equivalent to elacestrant 86.3 mg.
ORSERDU 345 mg film-coated tablets
Each film-coated tablet contains elacestrant dihydrochloride
equivalent to elacestrant 345 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
ORSERDU 86 mg
film-coated tablets
Blue to light blue biconvex round shaped film-coated tablet with ME
debossed on one side and plain
face on the opposite side. Approximate diameter: 8.8 mm.
ORSERDU 345 mg film-coated tablets
Blue to light blue biconvex oval shaped film-coated tablet with MH
debossed on one side and plain
face on the opposite side. Approximate size: 19.2 mm (length), 10.8 mm
(width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ORSERDU monotherapy is indicated for the treatment of postmenopausal
women, and men, with
estrogen receptor (ER)-positive, HER2-negative, locally advanced or
metastatic breast cancer with an
activating _ESR1_ mutation who have disease progression following at
least one line of endocrine
therapy including a CDK 4/6 inhibitor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ORSERDU should be initiated by a physician experienced
in the use of anticancer
therapies.
Patients with ER-positive, HER2-negative advanced breast cancer should
be selected for treatment
with ORSERDU based on the presence of an activating _ESR1_ mutation in
plasma specimens, using a
CE marked in vitro diagnostic (IVD) with the corresponding intended
purpose. If the CE-marked IVD
3
is not available, the pr